1. Field of the Invention
The present invention relates to an improved, automated infant massager, and more specifically, it relates to such a massager which is structured to be used on premature infants and can be adapted for use with full-term infants. The invention also relates to such an infant massager which can monitor infant behavioral, physical, and physiological conditions, and in an automated fashion, where appropriate, make adjustments to the massage. Network use of multiple infant massagers is also disclosed.
2. Description of the Prior Art
Hospitals aiming to improve the health status of premature infants must typically separate these babies from their parents at birth in order to administer the necessary medical interventions. Usually isolated in incubators that protect them, these preemies receive significantly less touching than full-term babies in the first days and weeks of life. In fact, many intensive care nurseries have, in the past, discouraged any “unnecessary” touching of neonates, in part because some early reports claimed that certain procedures involving handling, e.g., incubation and diaper changes, led to physiological disruptions, such as decreases in oxygen tension. To some extent, the medical community interpreted these reports as cautions against touching neonates in any other-than-essential manner until the 1987 study at Touch Research Institute (“TRI”) by Field et al., Field, T. et al., “Alleviating stress in ICU neonates,” Journal of the American Osteopathic Association, 87, 646, 650, (1987), which marked a turning point of premature touch therapy protocol. At TRI, Field et al. documented the effects of touch on forty premature infants. The researchers used a basic infant massage consisting of simple body strokes and passive limb movements for three fifteen-minute periods a day for ten days. The study results showed that the preemies who received massage: (1) averaged a 47 percent greater weight gain, even though the groups did not differ in average food intake (in calories or volume) (which increases their survival rate by 30%); (2) were awake and active a greater percentage of the time and (3) exhibited greater alertness, orientation, and responsiveness on the Brazelton Neonatal Behavior Assessment Scale. Despite the medical benefits of massage, it is time-consuming and requires a trained nurse, which makes its incorporation into the neonatal intensive care unit difficult due to the current nursing shortage, which is estimated to reach about one million by the year 2020.
Other studies have supported these findings and defeated the “common wisdom” about preterm neonates' presumed hyper-responsiveness to touch. Acolet et al., “The effect of mother-infant skin-to-skin contact on plasma cortisol and β-endorphin concentrations in preterm newborns 1,” Infant Behavior and Development, Volume 20, Issue 4, pp. 553-55, October-December 1997 discloses, for example, that gentle massage of the head and back of the ICU neonate does not increase the need for oxygen, but in fact, helps the infant cope physiologically with stress. Other studies showed greater weight gain, motor activity and alertness in preterm neonates who did not require intensive care. A meta-analysis by Ottenbacher et al., Oattenbacher K. J. et al., “The Effectiveness of tactile stimulation as a form of early intervention: a quantitative evaluation,” Journal of Developmental and Behavioral Pediatrics, 8:68-76, 1987, illustrated that most preterm infants were positively affected by touch stimulation, typically with greater weight gain and better performance on developmental tests. Follow-up research has suggested that massage has long-term benefits for premature infants. Eight months after being massaged in the neonatal ICU, the stimulated babies continued to gain more weight and perform better on developmental tests than a control group.
There are several infant pain and/or distress assessment techniques that clinicians utilize to assess infant, preterm and full term, distress and pain and/or distress level which include the Riley Pain and/or distress Scale, the Neonatal/Infant Pain and/or distress Scale (NIPS), and the Premature Infant Pain and/or distress Profile (PIPP), for example. These assessment techniques are well known to those skilled in the art. They have been validated and shown to be reliable techniques to characterize the pain and/or distress/agitation state of full-term and premature infants. See Duhn et al., “A Systematic Integrative Review of Infant Pain Assessment Tools,” Advances in Neonatal Care, Vol. 4, pp. 126-140, June 2004 and P. Hummel et al., “Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain,” Journal of Perinatology, Vol. 28, pp. 55-60, 2008. These tools provide clinicians with a discrete scale to characterize physiological and behavioral responses of an infant to determine pain and/or distress level. To use these techniques, clinicians rely on their individual expertise to discriminate the infant's physiological and behavioral pain and/or distress responses from other distress responses. There is not apparatus available to clinicians to provide massage or to autonomously characterize pain and/or distress level.
Despite the medical benefits of massage, it is time-consuming and requires a trained nurse, which makes its incorporation into the neonatal intensive care unit difficult.
Another reason why infant massage has not been widely implemented is due to the current nursing shortage, which is estimated to reach about one million by the year 2020.
U.S. Pat. No. 4,088,124 discloses an apparatus said to prevent apnea in a premature infant. This is accomplished by placing an infant on a waterbed and establishing controlled flow of fluid oscillations of the fluid of low amplitude and predetermined frequency under the infant.
Additional prior art patents of general interest are as follows:
TitlePat. No.Massage Apparatus7,322,946Mechanical Massaging Device7,175,592Massaging Device for Chairs with Guide Rail7,004,916Massaging Bed with Light6,814,709Objective Pain Measurement System and Method6,757,558Physiological Monitor Including an Objective6,751,499Pain MeasurementPortable Massager6,478,755Chair Massage6,454,731Cyclically Driven, Straightly and Reciprocally6,402,709Moving Massage DevicePortable Vibrating Sleep Pad6,175,981Massaging Blanket6,142,963Massaging Mattress6,052,852Pulsating Muscle Massaging Device5,951,501Body Contour Massage Device5,820,573Therapeutic Treatments Machine5,505,691Personal Cuddling & Massaging Device5,125,399Sleeping Inducing Devices5,063,912Massage Machine5,054,472Apparatus for Massaging the Body by Cyclic5,052,377Pressure & ConstituentElectrochemical Massage Apparatus4,834,075Punctual Massager Using Vertical Rotary4,777,945Movements of Massaging PinsTreatment of Colic Infants4,754,747Method & Apparatus for Therapeutic Motion and4,681,096Sound Treatments of InfantsMethod for Treating Premature Infants4,088,124Massage Device3,994,290